Pharmacy Market
PRNewswire | August 11, 2023
Capital Rx, the health technology company changing the way prescription drugs are priced and patients are cared for in America, has received a strategic investment from Memorial Hermann Health System, a non-profit health system committed to creating healthier Houston communities. Memorial Hermann joins Capital Rx's existing investors in supporting the development of JUDI®, the new standard for backend claims processing platforms in the pharmacy benefit management (PBM) industry, and the overall growth of Capital Rx's full-service PBM and pharmacy benefit administration (PBA) platform as a service (PaaS) solution.
"We're thrilled to have the investment support of Memorial Hermann as we work to modernize this country's claims processing infrastructure and deploy our aligned customer model to more employers, unions, municipalities, and other payers to create enduring change," said AJ Loiacono, Co-Founder & CEO of Capital Rx. "It's especially rewarding because we share the same values and prioritize community, compassion, credibility, and having the courage to be innovative in everything we do."
Capital Rx's JUDI brings exponential operational efficiency and control to Medicare, Medicaid, and commercial plans and prescription claims processing. A modern, open, and scalable platform, JUDI allows for seamless communication and data integration between vendors and across the continuum of care. Importantly, its intuitive design and workflows save time, allowing health systems and other payers to allocate resources more efficiently and toward what matters most: caring for patients and members in the communities and populations they serve.
"As we assessed the health care ecosystem for innovative capabilities to help accelerate the evolution of the pharmacy service model and prescription claims processing, Capital Rx's vision for a framework that prioritizes efficiency and allows for exceptional patient care set the company apart for investment consideration," said Feby Abraham, Ph.D., Executive Vice President and Chief Strategy Officer at Memorial Hermann. "Capital Rx's platform is focused on bringing clarity and consistency to drug prices, broadening access to medication, and helping its clients control pharmacy costs, all without sacrificing member service and patient outcomes."
The Health Management Academy's Strategic Partnership Alliance, which explores new venture and investment opportunities on behalf of a group of the country's largest health systems, identified Capital Rx as a mission-aligned disruptor with next-generation technology for its members, including Memorial Hermann.
About Memorial Hermann Health System
Charting a better future. A future that's built upon the HEALTH of our community. This is the driving force for Memorial Hermann, redefining health care for the individuals and many diverse populations we serve. Our 6,700 affiliated physicians and 32,000 employees practice the highest standards of safe, evidence-based, quality care to provide a personalized and outcome-oriented experience across our more than 260 care delivery sites. As one of the largest not-for-profit health systems in Southeast Texas, Memorial Hermann has an award-winning and nationally acclaimed Accountable Care Organization, 17* hospitals, and numerous specialty programs and services conveniently located throughout the Greater Houston area. Memorial Hermann-Texas Medical Center is one of the nation's busiest Level I trauma centers and serves as the primary teaching hospital for McGovern Medical School at UTHealth. For more than 115 years, our focus has been the best interest of our community, contributing nearly $500 million annually through school-based health centers and other community benefit programs. Now and for generations to come, the health of our community will be at the center of what we do – charting a better future for all.
Memorial Hermann Health System owns and operates 14 hospitals and has joint ventures with three other hospital facilities, including Memorial Hermann Surgical Hospital First Colony, Memorial Hermann Surgical Hospital Kingwood, and Memorial Hermann Rehabilitation Hospital-Katy.
About Capital Rx
Capital Rx is a healthcare technology company changing the way prescription drugs are priced and patients are cared for in America. As a Certified B Corp™, Capital Rx is executing its mission through an efficient Single-Ledger Model™ that increases visibility and reduces variability in drug prices. The company's cloud-native enterprise pharmacy platform, JUDI®, connects every aspect of the pharmacy ecosystem, servicing over 2.4 million members for Medicare, Medicaid, and commercial plans.
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Business Insights, PHARMACY MARKET
Businesswire | August 07, 2023
Mind Medicine Inc a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has entered into a license agreement with Catalent, a leader in enabling the development and supply of better treatments for patients worldwide, to access Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology.
Under the terms of the licensing agreement, Catalent has granted MindMed access to its Zydis technology for the development of MindMed’s lead product candidate MM-120 (lysergide D-tartrate), which is a proprietary, pharmaceutically optimized form of lysergide. The agreement also provides MindMed with exclusive rights for the use of the Zydis technology to develop all salt and polymorphic forms of lysergide in the United States, United Kingdom, and European Union among other key territories. Zydis ODT is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, without the need for water. Zydis is also recognized as one of the world’s best performing ODTs and has well-established advantages over conventional oral dosage forms, including improved patient compliance, adherence and convenience.
“We aim to develop best-in-class brain health treatments that have the potential to reach patients in need and are pleased to be working with Catalent, a global CDMO leader with broad, deep-scale expertise in delivery technologies, and multi-modality manufacturing capabilities to reach this objective”, said Robert Barrow, Chief Executive Officer and Director of MindMed. “ODT formulations have the potential to result in enhanced bioavailability and more rapid absorption, which could ultimately culminate in a shorter treatment session for MM-120. We believe that the Zydis ODT delivery technology, when incorporated into our MM-120 product candidate, represents an optimized pharmaceutical product that has the potential to enhance our competitive advantage in the marketplace and continue to expand our intellectual property estate. If granted, based on our current and ongoing applications that incorporate the Zydis ODT platform, MM-120 would benefit from numerous patents with first expiration dates beginning in 2042.”
“Catalent has a proven track record in working with partners to bring novel therapies through the clinic and to market quickly and we look forward to working with MindMed in the development of this potentially life-changing new product candidate,” said Tom Hawkeswood, President, Division Head of Pharma Product Delivery at Catalent. “The Zydis technology platform has been shown to be very versatile and effective in developing easy-to-administer dose forms for innovators, and its superiority over other ODTs has been illustrated by its use in the launch of more than 36 products in over 60 countries.”
MindMed is currently conducting a Phase 2b trial evaluating MM-120 for the treatment of generalized anxiety disorder (GAD) with topline data expected in the fourth quarter of 2023. This Phase 2b trial is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The participants are randomized to receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. The primary objective is to determine the reduction in anxiety symptoms four weeks after a single administration of MM-120, compared across the five treatment arms. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on our website (mindmed.co), the trial website (anxietyresearchstudy.com) or on clinicaltrials.gov (identifier NCT05407064). In addition, MindMed is in the process of initiating a Phase 1 pharmacokinetics bridging study to support advancement of the MM-120 ODT formulation into pivotal clinical trials.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
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PHARMACY MARKET
globenewswire | September 12, 2023
Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024.
Aquestive’s NDA for approval of Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027.
“The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.”
About Libervant
Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access.
About Aquestive
Aquestive is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.
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